Evaluation of TLL-018 Extended and Immediate Release Formulation for Bioequivalence Testing in Healthy Chinese Subjects

NCT05945810 | Completed Phase 1

• 1 other identifier: TLL-018-103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this two-sequence, two-cycle, single and multiple-dose Phase I clinical trial is To evaluate the human bioequivalence of the test preparation and the reference preparation in 28 healthy chinese subjects at a single center.

Conditions

Atopic Dermatitis

Keywords

Bioequivalence; Extended Release tablet

Outcome Measures

Primary Outcomes (3)

• Single Dose: AUC0-t

  Area under the blood concentration-time curve from time 0 to the last measurable time t after dosing

  Screening up to Day 17

• Single Dose: AUC0-∞

  Area under the blood concentration-time curve from time 0 to infinity after dosing

  Screening up to Day 17

• stable state: AUC0-24

  Area under the blood concentration-time curve from time 0 to 24 hours after dosing

  Screening up to Day 17

Study Arms (2)

sequence A

EXPERIMENTAL

In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days.

Drug: TLL-018 extended-release tablet; Drug: TLL-018 immediate-release tablet

sequence B

EXPERIMENTAL

In cycle 1, subjects in sequence B receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning on day 1 and another dose 12 hours later at night. From day 3 onward, they continue to receive 20-mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. After 3 days of washout, subjects receive a 50-mg single dose of TLL-018 extended-release tablet on day 11 In cycle 2, and once daily for 5 consecutive days from day 13 onwards.

Drug: TLL-018 extended-release tablet; Drug: TLL-018 immediate-release tablet

Interventions

TLL-018 extended-release tablet DRUG

50mg TLL-018 extended-release tablet QD

Also known as: extended-release tablet

sequence A; sequence B

TLL-018 immediate-release tablet DRUG

20mg TLL-018 immediate-release tablet BID

Also known as: immediate-release tablet

sequence A; sequence B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects can fully understand the purpose, method and possible adverse event of the study and are willing to participate and sign informed consent form prior to any study procedure;
• years (including 18 and 45 years);
• weigh: Male ≥50.0 kg, female ≥ 45.0kg, BMI between 19.0 and 26.0 kg/m2 (including boundary value);
• Without chronic or serious diseases history in cardiovascular, liver, kidney, blood and lymphatic, endocrine, immune, spiritual, menstrual and gastrointestinal systems, without dysphagia or any other effects on drug absorption history, no family history of genetic disease, and generally in good health;
• Vital signs examination (including boundary value) : systolic blood pressure 90\~139mmHg, diastolic blood pressure 60-89 mmHg, pulse 55-100 beats/min, body temperature (ear temperature) 36.0\~37.4℃. Physical examination, clinical laboratory examination, 12-lead electrocardiogram, anterolateral chest radiograph, Abdominal B-ultrasonography results all show no abnormality or no clinical significance;
• Female subjects are non-pregnant or non-lactating, and subjects and their partners are voluntary use of contraception deemed effective by the investigator for at least 4 weeks after the last investigational drug ;
• The subject is able to communicate well with the investigator and understand and comply with all aspects of the study.

You may not qualify if:

• People with a history of allergies, including but not limited to research drugs, foods or other substances;
• Any history of surgery, trauma that may affect the safety of the study or the in vivo course of the drug, or Patients scheduled to undergo surgery during the study period;
• Active or latent or inadequately treated mycobacterium tuberculosis infection in the 3 months prior to screening;
• Patients with clinically significant symptoms of infection within 30 days prior to screening or acute illness prior to the use of the investigational drug.
• Subjects with a history of herpes zoster within 1 year prior to screening; Subjects with a history of recurrent (unlimited) herpes zoster or disseminated herpes simplex or herpes zoster (even if only once);
• Those who received vaccination within 30 days prior to screening or planned to receive vaccination during the study period

Sponsors & Collaborators

• Hangzhou Highlightll Pharmaceutical Co., Ltd: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 318000, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible subjects screened will be randomly assigned to sequence A and sequence B in a 1:1 ratio. In cycle 1, subjects in sequence A receive a 50-mg single dose of TLL-018 extended-release tablet on day 1, and once daily for 5 consecutive days from day 3 onwards. After a 3-day washout period, subjects enter the cycle 2 at day 11 when they receive a 20-mg single dose of TLL-018 immediate-release tablet on the morning and another dose 12 hours later at night. From day 13 onward, they continue to receive 20 mg TLL-018 immediate-release tablets twice daily for 5 consecutive days. The subjects will be hospitalized for observation for 3 days after the end of medication. Subjects randomly assigned to sequence B received 20 mg of TLL-018 immediate-release tablets in cycle 1 and 50 mg extended-release tablet in cycle 2. The medication pattern was consistent with that of the subjects in sequence A. All the subjects took medicine after meal.

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 14, 2023
• Study Start: July 12, 2023
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: March 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)